To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
NCT ID: NCT00273468
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
630 participants
INTERVENTIONAL
2006-01-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Granisetron
Eligibility Criteria
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Inclusion Criteria
* Histologically and/or cytologically confirmed cancer with ECOG ≤2
* Life expectancy of ≥ 3 months
* Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days
Exclusion Criteria
* Contraindications to 5-HT3 receptor antagonists
* Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator
* Any cause for nausea and vomiting other than CINV
* Clinically relevant abnormal ECG parameters
* Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
* A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder
15 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
References
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Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; Sancuso Study Group. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011 Oct;19(10):1609-17. doi: 10.1007/s00520-010-0990-y. Epub 2010 Sep 12.
Other Identifiers
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392MD/15/C
Identifier Type: -
Identifier Source: org_study_id
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